Did the FDA Restrict Certain Peptides for Safety — or for Other Reasons?

When the FDA moved several well-known peptides—including BPC-157, TB-500 (thymosin beta-4 fragment), Epitalon, AOD-9604, and related research peptides (commonly compounded prior to 2023)—into a restricted category in 2023, the explanation most people heard was simple: “significant safety risks” and “lack of data.”

At first glance, that sounds alarming. It suggests danger. But when you slow down and examine what the FDA actually said—and just as importantly, what it did not say—a more nuanced and uncomfortable picture emerges.

This article isn’t about outrage or conspiracy. It’s about being honest with readers about how the system works, even when that honesty challenges powerful commercial interests.

What “Safety Risk” Meant in This Case

When regulators describe something as a safety risk, most people reasonably assume there must be clear evidence of harm—hospitalizations, toxicity, or documented deaths.

That wasn’t the case here.

The FDA did not claim that large numbers of people were injured. It did not point to documented toxicity in humans, nor did it cite clinical trials demonstrating clear danger. In fact, publicly available safety data do not show any confirmed deaths and only a very small number of isolated adverse event reports associated with peptide use, none of which establish causation.¹–²

Instead, the FDA’s language focused on uncertainty. The concern was that there wasn’t enough formal, sponsor-submitted human safety data to meet regulatory standards, especially for widespread use.

To put that in perspective, many fully FDA-approved, over-the-counter medications carry well-documented and quantifiable risks. Non-steroidal anti-inflammatory drugs (NSAIDs) are estimated to contribute to more than 15,000 deaths per year in the United States, largely due to gastrointestinal bleeding and cardiovascular events.³–⁴ Acetaminophen (Tylenol) is associated with approximately 400–500 deaths annually from acute liver failure, despite being widely regarded as safe when used as directed.⁵–⁶

That contrast doesn’t minimize the importance of safety. It highlights how differently risk is treated depending on whether a compound fits neatly into the traditional pharmaceutical model.

Why the “Lack of Data” Argument Keeps Appearing

Here is a critical point that often gets glossed over: the FDA does not generate safety data. It evaluates data submitted by sponsors.

For a compound to accumulate the kind of evidence regulators rely on, a company must fund large clinical trials, manage regulatory filings, and maintain long-term compliance. That process costs tens to hundreds of millions of dollars. It only happens when there is a clear profit potential tied to market exclusivity.

Many of the peptides that were restricted do not offer that pathway. They are relatively inexpensive, not easily patentable, and not owned by a single pharmaceutical sponsor. As a result, large human trials are rarely funded—not because the compounds lack biological relevance, but because there is no clear pathway to exclusivity and therefore insufficient profit potential to justify the cost of clinical development.

Without exclusivity, there is no reliable return on investment. Without profit potential, trials do not happen. Without trials, the FDA defaults to restriction.

That is not a scientific judgment. It is an economic one.

Why People Suspect Profit Plays a Role

There is no document proving the FDA explicitly restricted peptides to protect pharmaceutical company profits. No memo says that out loud.

But it would be naïve to ignore how the system is structured.

The modern drug-approval framework strongly favors compounds that are patentable, sponsor-funded, and commercially defensible. Those products move forward because someone stands to make money from them. Compounds that cannot be owned, controlled, or monopolized—even if biologically promising—struggle to survive in that environment.

So while profit protection may not be the stated goal, the outcome is predictable. The system advances what has profit potential and sidelines what does not.

That reality may not be comfortable, but it is observable.

Regulatory Risk Is Not the Same as Biological Risk

One of the most misleading aspects of this debate is the failure to distinguish regulatory risk from biological risk.

Regulatory risk is about uncertainty, liability, and control. It asks whether a compound fits into established approval pathways and clearly assigned responsibility. Biological risk asks whether a compound has been shown to cause harm in humans.

In the FDA’s Category 2 decisions, the emphasis was overwhelmingly on the former. The language used—“may present,” “potential,” “insufficient data”—reflects regulatory caution, not demonstrated danger.

That distinction matters, especially for readers trying to interpret alarming headlines.

Control Matters as Much as Safety

There is another factor rarely discussed openly: control.

Compounded peptides exist outside the traditional pharmaceutical pipeline. They are produced by multiple manufacturers, used in varied clinical contexts, and adopted rapidly through decentralized medical networks. From a regulatory perspective, that represents loss of centralized oversight.

When adoption outpaces regulatory frameworks, restriction becomes a way to reassert control—even if the science itself remains unsettled rather than disproven.

Seen through that lens, the FDA’s actions are easier to understand, even if one disagrees with them.

The Takeaway

Stepping back, several conclusions are difficult to avoid.

There is no public evidence that these peptides were restricted because widespread harm was occurring. The FDA’s actions were driven primarily by lack of sponsor-submitted human safety data, regulatory uncertainty, and a system that rewards exclusivity and profit potential over low-cost, unowned biology.

A fair and honest summary is this:

The FDA didn’t need to explicitly protect pharmaceutical profits. The structure of the system already does that by default.

Understanding that distinction helps separate fear from fact—and reminds us that regulatory decisions and biological reality are not always the same thing.

References

1. U.S. Food and Drug Administration. Certain Bulk Drug Substances That May Present Significant Safety Risks for Compounding. FDA; 2023.
2. U.S. Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances. FDA; 2023.
3. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. N Engl J Med. 1999;340(24):1888–1899.
4. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med. 1998;105(1B):31S–38S.
5. Larson AM, Polson J, Fontana RJ, et al. Acetaminophen-induced acute liver failure: results of a United States multicenter prospective study. Hepatology. 2005;42(6):1364–1372.
6. Lee WM. Acetaminophen toxicity: changing perceptions on a social/medical issue. Hepatology. 2007;46(4):966–970.